BioSure

A Message from Lord Pickles and Lord Blunkett, followed by BioSure's best practice article

The ability to listen and learn from one another has always been vital in parliament, in business and in most aspects of daily life. But at this particular moment in time, as national and global events continue to reiterate, it is uncommonly crucial that we forge new channels of communication and reinforce existing ones. The following article from BioSure is an attempt to do just that. We would welcome your thoughts on this or any other Parliamentary Review article.

Blunkett signature Rt Hon The Lord David Blunkett
Pickles signature Rt Hon The Lord Eric Pickles

www.hivselftest.co.uk

1BIOSURE |
BEST PRACTICE REPRESENTATIVE
CEO Brigette Bard
In the UK, BioSure’s HIVST
kits are available at over
1,200 stores nationwide, as
well as over 3,000 stores via
Boots and Superdrug online
click-and-collect services or
home delivery
BioSure is an in vitro diagnostic medical device company
that developed the world’s first approved blood-based HIV
self-testing kit. It aims to help create the first AIDS-free
generation, enabling people to take control of their health by
discreetly and accurately determining their HIV status on their
own terms. Founded in 2011, its strength lies in its ability to
balance tenacity and innovation with a focus on and passion
for delivering a top-quality product that disrupts the current
healthcare market. With an accuracy of 99.7 per cent, the
BioSURE HIV Self Test is the most accurate as well as the easiest
to use and simplest to read, all in under 15 minutes. CEO
Brigette Bard tells
The Parliamentary Review
more.
Despite great scepticism by healthcare professionals and regulators alike, we
maintain a steadfast belief that individuals want to self-diagnose. By changing
the existing and patronising mindset that people need to depend on doctors,
we play a crucial role in relieving the economic and practical burden on global
healthcaresystems.
In fact, providing a test that one can self-administer and obtain the results for in
privacy is beneficial to both individuals as well as underresourced and overstretched
national health systems across the world.
While great strides have been made to correct inaccurate and harmful beliefs
around HIV, pervasive stigma and persistent discrimination means that many still do
not access HIV services through traditional healthcare programmes.
FACTS ABOUT
BIOSURE
»CEO: Brigette Bard
»Established in 2011
»Based in Nazeing, Waltham
Abbey, Essex
»Services: Production of rapid
in-vitro diagnostic medical
devices, including the world’s
most accurate and first
approved blood-based HIV
self-testing kit
»No. of employees: 15
»BioSure’s global growth has
reached 500 per cent in the
last year alone
BioSure
THE PARLIAMENTARY REVIEW
Highlighting best practice
2| BIOSURE
Why is it so important that
people test themselves?
If an individual can test themselves,
they can discreetly take responsibility
for their own health and consequently
stay healthy. Self-testing also reaches
often-isolated key populations – such as
sex workers, people who inject drugs,
transgender persons and men who have
sex with men – who may not access HIV
services for a variety ofreasons.
Globally, there simply are not enough
doctors; I have always passionately
believed that self-testing is where
global healthcare is heading. For many
years, self-testing for HIV was not
legal, as it was considered a death
sentence, but antiretroviral treatments
are now so good that the virus can be
suppressed to undetectable levels.
In essence, we believe in preventative
care at an individual level, with a focus
on universal healthcare, whereby good
health becomes a right, not a privilege.
There are still an estimated 14 million
people undiagnosed globally, who are
unknowingly responsible for most of
today’s transmissions. In 2014, UNAIDS
established the ambitious “90-90-90
targets” for 2020: diagnosing 90 per
cent of all HIV patients, having 90 per
cent of those diagnosed on treatment
and ensuring 90 per cent of those
are virally suppressed with a view to
stopping transmission.
Testing remains the critical factor to
achieving these goals; if you don’t
know your status, you won’t know
to get treated. We play a vital role
in ending the epidemic through
increasing access to testing by
providing choice and utilising well
thought-out marketing to increase
education and awareness, driving the
conversation into the mainstream and
eliminating stigma as a consequence.
It is important to know that, as long
as you have an undetectable viral load,
you cannot pass HIV onto either a
partner during sexual intercourse or to
a child through labour or breastfeeding.
Challenging accepted truths
Part of our success is attributed to
boldly and relentlessly pushing current
industry boundaries in pursuit of an
aim we have always known to be
true: most people want to live and
improve their health if they can. If we
can help people to test and determine
their HIV status, they will be more
likely to seek out care and treatment
whereavailable.
In fact, data by independent bodies
is now proving this to be true and
has even influenced WHO policies
and procedures to include guidelines
for HIVST practices into programmes
working towards national and
international HIV goals.
Nearly 37 million people are living with
HIV/AIDS today, and more than 25 per
cent are not on life-saving treatment,
because they do not know their status.
This is something we believe we can help
to change, but it will take true leadership
across the private and public sectors.
The UK’s first CE-
marked HIV self test
allows customers to self
test for HIV accurately,
comfortably and
confidentially with three
easy steps: a prick, a
suck and a poke
We believe in
preventative
care at an
individual level,
with a focus
on universal
healthcare
3BIOSURE |
BEST PRACTICE REPRESENTATIVE
Over the last several years, the greatest
hurdle we have had to overcome
is a variety of regulatory barriers –
convincing regulators, ministries of
health and policymakers that self-
testing is a good idea.
We consequently developed a
multipronged approach to working with
such a diverse range of stakeholders
– from governments and regulatory
bodies to global donor funds,
grassroots NGOs, medical professionals
and end consumers – to change
people’s mindsets around HIV. With a
presence in three continents, we are
already proving that self-testing works.
Maintaining presence in a
difficult market
Working in a highly regulated market
always comes with its challenges; the
upside is that because the barriers to
entry are high, the number of true
competitors in the market is low. Firstly,
our blood test distinguishes us from
oral-fluid tests on the market; while
HIV antibodies are present in oral fluid,
the concentration is low and oral-fluid
tests are consequently less sensitive.
Another critical factor is that, in
order to obtain CE marking, HIVSTs
have to have an inbuilt mechanism
that clearly indicates to an untrained
end-user whether the test was
performed correctly. Our HIVST has
an inbuilt sample control line, so if it
is performed incorrectly, for instance
with insufficient blood or another
liquid, no lines will appear and the user
knows their test hasn’t worked. This is
a crucial distinguishing factor between
our test and others on the market and
is unfortunately not fully understood
by global regulators.
Remaining resolute
It is this careful attention to detail and
deep understanding of both the problem
and the individual end-user that sets
us apart from competitors in terms of
quality, product, messaging and delivery.
This relentless focus stems from our
passion to help build confidence and
credibility in the self-testing sector. It has
always been my personal ambition to
establish BioSure as a trusted and credible
self-test brand that people can rely on,
and we are firmly moving into that space.
Following successful launches in the UK,
Europe and South Africa, our global
rollout is well underway with a presence
in Brazil, Kenya and Ghana; approvals
are also underway for eight other global
markets. In the future, we believe there
will be a self-test for virtually everything,
and while the sector is fully focused on
HIV for now, research and development
is underway to create a suite of accurate
and easy-to-use BioSURE self-tests.
Although self-testing is now starting
to be utilised in low-income countries,
our disruptive innovation that was
developed and initially launched in the
UK has been ignored by Public Health
England, who continually refuse to
integrate HIV self-testing into their
programmes despite overwhelming
evidence of its beneficial applications.
Nevertheless, our overwhelming
confidence and belief in this market
led us to invest in reshoring our
manufacturing to the UK in 2018, and
we have plans to extend that investment
as our business continues to scale.
If we can help
people to test
and determine
their HIV status,
they will be
more likely to
seek out care
and treatment
where available
BioSure specialises in
sexual health and is
committed to delivering
cost-effective, fast and
accurate healthcare
underpinned with a
fundamental belief in
self-testing

www.hivselftest.co.uk

This article was sponsored by BioSure. The Parliamentary Review is wholly funded by the representatives who write for it. The publication in which this article originally appeared contained the following foreword from Rt Hon Michael Gove.

Rt Hon Michael Gove's Foreword For The Parliamentary Review

By Rt Hon Michael Gove

This year's Parliamentary Review comes at a momentous time for parliament, as we collectively determine the destiny of the United Kingdom. 

On October 31, the UK will leave the European Union. The successful implementation of this process is this government's number-one priority.

Three years after a historic referendum vote, we will deliver on the decisive mandate from the British people. Trust in our democracy depends on it. Until that final hour, we will work determinedly and diligently to negotiate a deal, one that abolishes the backstop and upholds the warm and close relationship we share with our friends, allies and neighbours in the EU. But in the event that the EU refuses to meet us at the table, we must be prepared to leave without a deal.

As the Chancellor of the Duchy of Lancaster, it is my job to lead on this government's approach, should that scenario happen. Preparing for Brexit is my department's driving mission. But while I am leading this turbocharged effort, the whole of government is committed to this endeavour.

Ministers across Whitehall are working together to ensure that every possibility is considered, every plan is scrutinised and every provision is made. A daily drumbeat of meetings means that we are holding departments accountable, so that preparations are completed on time.

The chancellor has confirmed that all necessary funding will be made available. And we have mobilised thecivil service, assigning 15,000 of our most talented civil servants to manage our exit from the EU.

We will make sure that on November 1, there is as little disruption to national life as possible. Our trade relationships will continue to thrive, thanks to agreements with countries around the world worth £70 billion. Our country will remain secure, thanks to nearly 1,000 new officers posted at our borders. And the 3.2 million EU nationals now living and working among us can remain confident, with absolute certainty, of their right to remain in the UK.

Above all, our goal is to be transparent. Soon, we will launch a public information campaign so that citizens, communities and businesses are ready and reassured about what will happen in the event of “no deal”.

In my first few weeks in this role, I have travelled to ports and tarmacs, borders and bridges, all across the UK –from the seaside of Dover to the rolling green hills of County Armagh. I have heard from business owners and border officials, farmers and hauliers. They are ready to put an end to uncertainty. And they are ready to embrace the opportunities ahead.

Our departure from the EU will be a once in a lifetime chance to chart a new course for the United Kingdom. Preparing for that new course will be a herculean effort. But this country has made astounding efforts before. We can do it again.
Rt Hon Michael Gove
Chancellor of the Duchy of Lancaster